DEVICE: Tyvek Heat Seal Pouch (10705037015900)

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Device Identifier (DI) Information

Tyvek Heat Seal Pouch
12541
12541
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
10705037015900
GS1
250
Tyvek Heat Seal Pouch with Sterrad Chemical Indicator 200 mm x 400 mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Sterilization packaging, single-use A device intended to be used to enclose medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.
Chemical/physical sterilization process indicator A sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FRG Wrap, sterilization
JOJ Indicator, physical/chemical sterilization process
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20705037015907 2 10705037015900 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 80705037015909 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(888)783-7723
complaints@aspus.jnj.com
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